Analgesia, Children, Local Anesthesia, Ropivacaine, Tonsillectomy
Conditions
Brief summary
Tonsillectomy is one of the most frequently performed surgical procedures in children and is commonly associated with significant postoperative pain. Peritonsillar infiltration with local anesthetics such as Ropivacaine has been proposed to improve analgesia, but evidence remains inconsistent. This study aimed to evaluate the analgesic efficacy of peritonsillar Ropivacaine infiltration in pediatric tonsillectomy.
Interventions
OTHERPeritonsillar infiltration with ropivacaine
Under general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with ropivacaine was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule.
OTHERPeritonsillar infiltration with normal saline
Under general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with normal saline was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule.
DRUGNormal Saline
Normal saline 0.9%, 5 mL, administered (2.5 mL per tonsillar bed)
Ropivacaine 0.2%, 5 mL, administered (2.5 mL per tonsillar bed)
Sponsors
University Hospital, Mahdia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double (Participant; Outcomes Assessor)
Intervention model description
The patients will be randomized to be allocated to 2 groups by a computer-generated randomization table into two equal groups
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 3-6 years * classified as ASA I-II * scheduled for elective tonsillectomy without adenoidectomy
Exclusion criteria
* systemic diseases (hepatic, renal, hematologic, or cardiac) * obesity (BMI ≥ 95th percentile) * upper respiratory infection within two weeks * chronic analgesic use * known allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first postoperative analgesic request | From the end of surgery until 24 hours postoperatively | Time from the end of surgery to the first administration of rescue analgesic medication. The time was recorded in hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative remifentanil dose (µg) | Perioperative. | It refers to the total dose of remifentanil administered to the patient during the entire surgical procedure. It reflects the amount of opioid used for intraoperative analgesia. |
| Paracetamol Consumption at 24h | In the first 24 hours postoperatively | It refers to the total dose of paracetamol consumed in the first 24 hours postoperatively, normalized per kilogram of body weight (mg/kg). |
| Time to first oral intake | From the end of surgery until first oral intake, assessed during the first 24 hours after surgery. | Time from the end of surgery to the first oral intake, expressed in hours. |
| Face, Legs, Activity, Cry, Consolability scores over 24h | At 0, 2, 4, 8, 12 and 24 hours after surgery | Postoperative pain intensity assessed using the Face, Legs, Activity, Cry, Consolability scale (FLACC), ranging from 0 (no pain) to 10 (worst possible pain). |
| Parental satisfaction | At 24 hours after surgery | Parents' satisfaction was assessed using a 5-point Likert scale, where 1 indicated very dissatisfied, 5 very satisfied. |
| Incidence of adverse effects | Perioperative. | Occurrence of adverse effects (hypotension, bradycardia, arrhythmia, or local anesthetic toxicity) during or after surgery. |
| Need for rescue tramadol | Perioperative. | Once the FLACC score will be ≥ 4, rescue analgesia in the form of tramadol will be given. |
| Surgical conditions | Perioperative. | It refers to the surgical dissection evaluated by the surgeon, easy, moderately easy or hard. |
| Intraoperative systolic blood pressure | Perioperative. | It refers to the the systolic blood pressure collected intraoperatively every ten minutes. |
| Intraoperative diastolic blood pressure. | Perioperative. | It refers to the diastolic blood pressure collected intraoperatively every ten minutes. |
| Intraoperative heart rate | Perioperative. | It refers to the heart rate collected intraoperatively every ten minutes. |
Countries
Tunisia
Outcome results
None listed